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Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease
Sponsor: Beijing Anzhen Hospital
Summary
This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.
Official title: An Active Post-Market Surveillance Study Assessing the Real-World Clinical Applicability, Long-Term Safety, and Effectiveness of Innovative Medical Devices for Valvular Heart Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5500
Start Date
2026-05-10
Completion Date
2029-01-31
Last Updated
2026-05-26
Healthy Volunteers
No
Interventions
Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement
Transcatheter Edge-to-Edge Repair
Transcatheter Edge-to-Edge Repair
Transcatheter Tricuspid Valve Annuloplasty
Transcatheter Tricuspid Valve Annuloplasty
Surgical Aortic Valve Replacement
Surgical Aortic Valve Replacement
Locations (1)
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China